Calendario›SNY›CYD Dengue Vaccine
CYD Dengue Vaccine
Study of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects
Ensayo de Sanofi en Dengue Fever · Dengue Hemorrhagic Fever (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Interrumpido
- Participantes
- 688
- Centros
- 4
- Fin del objetivo primario
- dic 2019
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en dic 2016.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «No answer received from the Philippines Food and Drug Administration on protocol amendment issued due to IDMC recommendations. CYD vaccine 3rd dose not given.».
Qué mide
Geometric Mean Concentrations (GMCs) of Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) 28 Days After Dose of Tdap Vaccine in Previously Dengue Immune Participants (28 days after Tdap vaccination) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe aim of the study was to investigate the immunogenicity and safety of CYD dengue vaccine and Tetanus Toxoid (T), Reduced Diphtheria Toxoid (D) and Acellular Pertussis Vaccine Adsorbed (ap) (Tdap) vaccine when both vaccines were administered concomitantly or sequentially. Primary Objectives: * To demonstrate the non-inferiority of the humoral immune response to the Tdap booster dose concomitantly administered with the first dose of CYD dengue vaccine as compared to sequential administration, measured 28 days after Tdap booster dose. * To demonstrate the non-inferiority of the humoral immune response to the first dose of CYD dengue vaccine concomitantly administered with Tdap as compared to sequential administration, measured 28 days after the first dose of CYD dengue vaccine. Secondary Objectives: * To demonstrate the non-inferiority of the humoral immune response of 3 doses of CYD dengue vaccine with the first dose concomitantly administered with Tdap as compared to sequential administration, measured 28 days after the third dose of CYD dengue vaccine. * To describe the humoral immune response at baseline and 28 days after the first and third doses of CYD dengue vaccine, in each and any group. * To describe the humoral immune response of Tdap vaccine at baseline and 28 days after concomitant administration with the first dose of CYD dengue vaccine as compared to the sequential administration, in each and any group. * To describe the safety of the CYD dengue vaccine and of the Tdap booster dose after each and any injection in each group.
Más ensayos de SNY
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Avalglucosidase alfa · Mini-COMET | Fase 2 | En marcha, sin reclutar | sep 2019 (real) |
| Yellow fever vaccine | Fase 2 | En marcha, sin reclutar | may 2022 (real) |
| Yellow fever vaccine · VYF02 | Fase 2 | En marcha, sin reclutar | jun 2022 (real) |
| SAR441344 IV | Fase 2 | En marcha, sin reclutar | sep 2022 (real) |
| Meningococcal Polysaccharide | Fase 3 | En marcha, sin reclutar | mar 2023 (real) |
| Isatuximab IV · IRAKLIA | Fase 3 | En marcha, sin reclutar | nov 2024 (real) |
Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02992418), actualizada en mar 2022.